HERTFORDSHIRE, England and
PITTSBURGH and BENGALURU,
India, Jan.
29, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) and
Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that
the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) has issued a positive opinion recommending
approval of Semglee™, insulin glargine, a long-acting
insulin analog used in the treatment of diabetes mellitus in
adults, adolescents and children aged 2 years and above.
The CHMP positive opinion will be considered by the European
Commission. The European Commission decision on the approval is
expected in April.
Mylan President Rajiv Malik
commented, "We are pleased with CHMP's decision to recommend
approval of Mylan and Biocon's biosimilar insulin glargine. With
approximately 60 million people living with diabetes in the
European Region and prevalence on the rise, we have an important
role to play to help increase access to high-quality, more
affordable treatment options for patients. Mylan is a global leader
in the development and manufacturing of complex products, and we
are proud of our regulatory, clinical and scientific capabilities
that have allowed us to reach this important milestone."
Arun Chandavarkar, CEO and Joint
Managing Director, Biocon said, "CHMP's decision to recommend
approval of Biocon and Mylan's biosimilar insulin glargine brings
us a step closer to offer high quality, affordable options for
people with diabetes in the EU. This is an outcome of our
commitment to be a credible, global insulins player on the back of
significant investments together with our partner Mylan in global
scale manufacturing and R&D after
having previously obtained approvals for our insulin glargine in
Japan and key emerging
markets."
Data submitted as part of the Marketing Authorization
Application included analytical similarity data, metabolic assays,
euglycemic clamp data in type 1 diabetes patients for demonstration
of similar PD and PK response, as well as robust clinical endpoint
studies in patients with Type 1 and Type 2 Diabetes comparing
Semglee with the reference product, insulin glargine to demonstrate
similar safety, efficacy and immunogenicity up to 52 weeks.
In addition to the European submission, marketing applications
for Semglee have been submitted in Australia, Canada, and the U.S. and are planned for key
Emerging Markets.
About the Mylan and Biocon Collaboration
Biocon and
Mylan are exclusive partners on a broad portfolio of biosimilars
and insulin analogs. Glargine is one of the three insulin analogs
being co-developed by Mylan and Biocon for the global marketplace.
Mylan has exclusive commercialization rights for insulin glargine
in the U.S., Canada, Australia, New Zealand, the
European Union and European Free Trade Association countries.
Biocon has exclusive rights for Japan and a few emerging
markets, and co-exclusive commercialization rights with Mylan in
the rest of the world.
About Mylan
Mylan is a global pharmaceutical company
committed to setting new standards in healthcare. Working together
around the world to provide 7 billion people access to high quality
medicine, we innovate to satisfy unmet needs; make reliability and
service excellence a habit; do what's right, not what's easy; and
impact the future through passionate global leadership. We offer a
growing portfolio of more than 7,500 marketed products around the
world, including antiretroviral therapies on which more than 40% of
people being treated for HIV/AIDS globally depend. We market our
products in more than 165 countries and territories. We are one of
the world's largest producers of active pharmaceutical ingredients.
Every member of our approximately 35,000-strong workforce is
dedicated to creating better health for a better world, one person
at a time. Learn more at Mylan.com. We routinely post information
that may be important to investors on our website at
investor.mylan.com.
About Biocon
Biocon Limited, publicly listed in 2004,
(BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is
India's largest and
fully-integrated, innovation-led biopharmaceutical company. As an
emerging global biopharmaceutical enterprise serving customers in
over 120 countries, it is committed to reduce therapy costs of
chronic diseases like diabetes, cancer and autoimmune. Through
innovative products and research services it is enabling access to
affordable healthcare for patients, partners and healthcare systems
across the globe. It has successfully developed and taken a range
of Novel Biologics, Biosimilars, differentiated Small Molecules and
affordable Recombinant Human Insulin and Analogs from 'Lab to
Market'. Some of its key brands are INSUGEN® (rh-insulin), BASALOG®
(Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab),
KRABEVA ® ( Bevacizumab) and ALZUMAb™ (Itolizumab), a 'first in
class' anti-CD6 monoclonal antibody. The Company has a rich
pipeline of Biosimilars and Novel Biologics at various stages of
development including Insulin Tregopil, a high potential oral
insulin.
Forward-Looking Statements: Mylan
This press
release includes statements that constitute "forward-looking
statements," including with regard to: approval of Semglee; that
the European Commission decision on the approval is expected
in April; and that we have an important role to play to help
increase access to high-quality, more affordable treatment options
for patients. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Because such statements inherently involve risks and uncertainties,
actual future results may differ materially from those expressed or
implied by such forward-looking statements. Factors that could
cause or contribute to such differences include, but are not
limited to: success of clinical trials and our or our partners'
ability to execute on new product opportunities; any regulatory,
legal or other impediments to our or our partners' ability to bring
products to market; other risks inherent in product development;
the scope, timing, and outcome of any ongoing legal proceedings,
including government investigations, and the impact of any such
proceedings on our or our partners' businesses; actions and
decisions of healthcare and pharmaceutical regulators, and changes
in healthcare and pharmaceutical laws and regulations, in the
United States and abroad; the impact of competition;
strategies by competitors or other third parties to delay or
prevent product introductions; the effect of any changes in our or
our partners' customer and supplier relationships and customer
purchasing patterns; any other changes in third-party
relationships; changes in the economic and financial conditions of
the businesses of Mylan or its partners; uncertainties and matters
beyond the control of management; and the other risks detailed in
Mylan's filings with the Securities and Exchange Commission. Mylan
undertakes no obligation to update these statements for revisions
or changes after the date of this release.
Forward-Looking Statements: Biocon
This Press
Release may include forward-looking information to enable investors
to comprehend our prospects and take informed investment decisions.
The statements - written and oral - that we periodically make
contain forward looking statements that set out anticipated results
based on the management's plans and assumptions. We have tried
wherever possible to identify such statements by using words such
as 'anticipates', 'estimates', 'expects', 'projects', 'intends',
'plans', 'believes' and words of similar substance in connection
with any discussion of future performance. The market data &
rankings used, are based on several published reports and internal
company assessment. We cannot guarantee that these forward- looking
statements will be realized, although we believe we have been
prudent in our assumptions. The achievement of results is subject
to risks, uncertainties and even inaccurate assumptions. Should
known or unknown risks or uncertainties materialize, or should
underlying assumptions prove inaccurate, actual results could vary
materially from those anticipated, estimated or projected. Readers
should bear this in mind. We undertake no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
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SOURCE Mylan N.V.